Losec 20 mg gastro-resistant hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Losec 20 mg gastro-resistant hard capsules

Omeprazole

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Losec is and what it is used for

2. What you need to know before taking Losec

3. How to take Losec

4. Possible side effects

5. How to store Losec

6. Contents of the pack and other information

1. What Losec is and what it is used for

Losec contains the active substance omeprazole. It belongs to a group of medicines called "proton pump inhibitors". These medicines work by reducing the amount of acid produced by the stomach.

Losec is used to treat the following conditions:

In adults:

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid passes into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected with a bacterium called "Helicobacter pylori". If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Losec may also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and ≥ 10 kg

• "Gastroesophageal reflux disease" (GERD). In this disorder, stomach acid passes into the esophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn. In children, symptoms of the disease may include return of stomach contents to the mouth (regurgitation), vomiting, and inadequate weight gain.

Children over 4 years of age and adolescents

• Ulcers infected with a bacterium called "Helicobacter pylori". If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Losec

Do not take Losec:

• If you are allergic to omeprazole or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to medicines containing proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• If you are taking a medicine containing nelfinavir (used for HIV infection).

Do not take Losec if any of the above apply to you. If you are unsure, speak with your doctor or pharmacist before taking Losec.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Losec.

Severe skin reactions have been reported with Losec treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking Losec and contact your doctor immediately if you experience any of these symptoms related to severe skin reactions described in section 4.

Losec may mask symptoms of other conditions. Therefore, if you experience any of the following conditions before starting or during treatment with Losec, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• New onset of vomiting food or vomiting blood.
• Black stools (blood in faeces).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Losec used to reduce stomach acid.
• If you are scheduled to have a specific blood test (chromogranin A).

If you take Losec for a long period (more than 1 year), your doctor may schedule periodic check-ups. You should report any new or unusual symptoms or circumstances during your visits.

Taking a proton pump inhibitor such as Losec, especially for more than one year, may slightly increase the risk of fracture of the hip, wrist, or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase the risk of osteoporosis).

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with Losec may need to be discontinued. Remember to mention any other symptoms you may notice, such as joint pain.

Kidney inflammation may occur while taking omeprazole. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, rash, and joint stiffness. You should report these signs to your treating doctor.

This medicine may affect how your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low vitamin B12 levels:

• Extreme tiredness or lack of energy
• Tingling
• Tongue pain or red, sore tongue, mouth ulcers
• Muscle weakness
• Vision changes
• Memory problems, confusion, depression

Children

Some children with chronic conditions may require long-term treatment, although this is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and Losec

Taking Losec with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. This is because Losec can affect how some medicines work, and some medicines can affect Losec.

Do not take Losec if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are taking any of the following medicines:

• Ketoconazole, itraconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles, or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping treatment with Losec
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when starting or stopping treatment with Losec
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in organ transplantation)
• St John’s wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (chemotherapy medicine used in high doses to treat cancer) – if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with Losec.

If your doctor has prescribed you the antibiotics amoxicillin and clarithromycin in addition to Losec to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them of any other medicines you are taking.

Taking Losec with food and drink

See section 3.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Omeprazole passes into breast milk, but is unlikely to affect the infant when therapeutic doses are used. Your doctor will decide whether you can take Losec while breast-feeding.

Driving and using machines

Losec is unlikely to affect your ability to drive or use tools or machines. However, adverse effects such as dizziness and visual disturbances may occur (see section 4). If they occur, patients should not drive or use machines.

Losec capsules contain lactose and sodium

Losec capsules contain lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Losec capsules contain less than 23 mg of sodium (1 mmol) per capsule; this is essentially “sodium-free”.

3. How to take Losec

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and your age.

The recommended dose is described below:

Use in adults

Treatment of symptoms of GERD (gastroesophageal reflux disease), such as heartburn and acid regurgitation:

• If your doctor confirms that you have mild damage to the esophagus, the recommended dose is 20 mg once daily for 4 to 8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the esophagus has not yet healed.

• The recommended dose once the esophagus has healed is 10 mg once daily.

• If you do not have esophageal damage, the usual dose is 10 mg once daily.

Treatment of ulcers in the upper part of the intestine (duodenal ulcer):

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of stomach ulcers (gastric ulcer):

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Prevention of recurrence of stomach and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

Treatment of stomach and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once daily for 4 to 8 weeks.

Prevention of stomach and duodenal ulcers during NSAID treatment:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by infection with Helicobacter pylori and prevention of their recurrence:

• The recommended dose is 20 mg of Losec twice daily for one week.

• Your doctor will also instruct you to take two antibiotics from the following: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess stomach acid caused by a tumor in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg per day.
• Your doctor will adjust the dose according to your needs and will also decide how long you should take the medicine.

Use in children and adolescents

Treatment of symptoms of GERD, such as heartburn and acid regurgitation

• Children over one year of age who weigh more than 10 kg may take Losec. The dose for children is based on body weight, and the doctor will decide the correct dose.

Treatment of ulcers caused by infection with Helicobacter pylori and prevention of their recurrence:

• Children over 4 years of age may take Losec. The dose for children is based on body weight, and the doctor will decide the correct dose.
• The doctor will also prescribe two antibiotics for your child: amoxicillin and clarithromycin.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may take your capsules with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules that prevent the medicine from breaking down due to stomach acid. It is important not to damage the granules.

What to do if you or your child have difficulty swallowing the capsules

• If you or your child have difficulty swallowing the capsules:
  • Open the capsule and swallow the contents directly with half a glass of water, or pour the contents into a glass of still water, acidic fruit juice (e.g., apple, orange, or pineapple juice), or apple puree.
  • Always shake the mixture well just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
  • To ensure that all the medicine has been taken, fill the glass halfway with water, swirl it well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Losec than you should

If you have taken more Losec than prescribed by your doctor, consult your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Losec

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.

If you stop taking Losec

Do not stop treatment with Losec without first talking to your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious side effects, stop taking Losec and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction). (rare)
• Reddening of the skin with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals may also occur. This could be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”. (very rare)
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). (rare)
• A widespread, red, scaly rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). (rare)
• Yellowing of the skin, dark urine and tiredness, which may be signs of liver problems. (rare)

Other adverse effects are:

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache
• Stomach or intestinal problems: diarrhoea, stomach pain, constipation and gas (flatulence)
• Nausea or vomiting
• Benign polyps in the stomach

Uncommon adverse effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles
• Sleep disorders (insomnia)
• Dizziness, tingling sensation, drowsiness
• Sensation of spinning (vertigo)
• Abnormalities in blood tests used to monitor liver function
• Skin rash, hives and itching
• General feeling of being unwell and lack of energy

Rare adverse effects (may affect up to 1 in 1,000 people)

• Blood problems, such as a decrease in white blood cells or platelets. This may cause weakness or bruising and increase the likelihood of developing infections.
• Low blood sodium levels. This may cause weakness, vomiting and cramps.
• Restlessness, confusion or depression
• Taste disturbances
• Vision problems, such as blurred vision
• Sudden sensation of difficulty breathing (bronchospasm)
• Dry mouth
• Inflammation inside the mouth
• Fungal infection called “candidiasis” that may affect the intestine
• Hair loss (alopecia)
• Skin rash upon exposure to sunlight
• Joint pain (arthralgia) or muscle pain (myalgia)
• Serious kidney problems (interstitial nephritis)
• Increased sweating

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells)
• Aggressiveness
• Seeing, feeling or hearing things that are not real (hallucinations)
• Serious liver problems leading to liver failure and brain inflammation
• Erythema multiforme
• Muscle weakness
• Enlargement of the breasts in males

Frequency not known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhoea)

• If you are being treated with Losec for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

• Rash, possibly with joint pain

In very rare cases, Losec may affect the white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a very poor general condition, or fever with signs of local infection such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you provide information about the medicines you are taking at that time.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losec

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton or blister pack after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep this medicine in its original packaging (blister) to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Losec

• The active substance is omeprazole. Each capsule (gastro-resistant capsule) contains 20 mg of omeprazole.

• The other components are disodium phosphate dihydrate, low-substituted hydroxypropylcellulose, hypromellose, anhydrous lactose, magnesium stearate, mannitol, methacrylic acid-ethyl acrylate copolymer (1:1) 30% dispersion, microcrystalline cellulose, macrogol (polyethylene glycol 400), sodium lauryl sulfate, iron oxide E172, titanium dioxide E171, gelatin, printing ink (containing shellac, ammonia, potassium hydroxide and black iron oxide E172), colloidal anhydrous silica and liquid paraffin. See section 2 "Losec contains lactose".

Appearance of the product and contents of the pack

• Losec 20 mg capsules consist of a pink body marked with "20" and a reddish-brown cap marked with "A/OM".

Pack sizes:

• 20 mg: Blister packs of 14 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Local Representative:

Laboratorios Rubió, S.A.
Industria, 29
Pol. Ind. Comte de Sert
08755 Castellbisbal (Barcelona)
Spain

Manufacturer

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 23-24, 17489 Greifswald, Germany

This medicinal product is authorized in European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Date of the most recent review of this leaflet: August 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/